Ics3 Pink Antiseptic Hand Wash
FDA Label NDC 81232-162
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biocentris Pharmaceuticals, Llc for the product Ics3 Pink Antiseptic Hand Wash (NDC 81232-162). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient
Benzalkonium chloride 0.13% (w/w)
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
Uses
For hand washing to decrease bacteria on the skin after changing diapers, after assisting ill persons or before contact with a person under medical care or treatment. Recommended for repeated use.
Warnings
Warnings
- For external use only. Keep out of eyes, ears or mouth.
Otc - Stop Use
- Discontinue use if irritation occurs
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children.
Dosage & Administration
Directions
- Dispense a golf ball size amount of foam onto dry hands and rub vigorously for 15 seconds
- Rinse with water and towel dry.
Inactive Ingredient
Inactive ingredients
Cetrimonium cloride, chlorhexidine glluconate, cocamidopropyl PG-dimonium chloride phosphate, D & C Red #33, decyl glucoside, ethyl alcohol, phenoxyethanol, polyquaternium 10, polyquarternium 11, water.
Package Label.Principal Display Panel
iCS3®
INFECTION CONTROL SYSTEM 3
ANTISEPTIC HAND WASH
34 FL PZ (1000 mL)
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